Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity

NCT04642456 | Recruiting

• 1 other identifier: S61860
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Develop reliable methods for functional assessment, for trunk strength, of Adult Spinal Deformity (ASD) patients and create a first clinical and normative database

1. 1.Compare functionality of ASD and control subjects
2. 2.Relate functionality of ASD patients to their pathology, in terms of spinal deformity and muscle condition

Conditions

Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• Trunk muscle strength

  Trunk muscle strength is measured according to a trunk strength hand-held dynamometer protocol and repeated within two weeks after the first measurement to assess both interrater and test-retest reliability.

  From screening till week 2

Secondary Outcomes (1)

• Static 2D radiographic evaluation of spinopelvic parameters

  Day 1

Study Arms (2)

Control group

OTHER

Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam

Diagnostic Test: Trunk strength measurement; Diagnostic Test: EOS stereoradiographic full body exam

ASD group

OTHER

Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2

Diagnostic Test: Trunk strength measurement; Diagnostic Test: EOS stereoradiographic full body exam

Interventions

EOS stereoradiographic full body exam DIAGNOSTIC_TEST

Every subject included in the study will undergo a stereoradiographic full body EOS exam completed with Gravity Line (GL) location, recorded by a force plate on the floor

ASD group; Control group

Trunk strength measurement DIAGNOSTIC_TEST

A trunk strength protocol in sitting position, using a hand-held dynamometer is developed.

ASD group; Control group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.
• Ability to walk at least 50 meters distance independently without a walking aid.
• No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.
• Adults (\> 18 year old)
• No current history of back pain and spinal deformity.
• Ability to walk at least 1000 meters distance independently without a walking aid.
• No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.

You may not qualify if:

• Age \< 18 years old and \> 79 years old
• Absence of adult spinal deformity
• Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
• Missing patient informed consent
• Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
• Patients with a history of spinal fusion surgery.
• Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\> 3 cm)
• Age \< 18 years old and \> 79 years old
• Backpain and/or Sciatica at time of the study
• Presence of adult spinal deformity leading to a pathological sagittal alignment
• Non-ability to walk at least 1000 meters distance independently without a walking aid
• Missing patient informed consent
• Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion
• Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\> 3 cm)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Officials

• Lieven Moke

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven Moke

CONTACT

+32 16 34 08 84; lieven.moke@uzleuven.be

Anna a Tarasiuk

CONTACT

003216 338818; orthopedie.research@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: control group with healthy subjects and patient group with spinal deformity (ASD)

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 24, 2020
• Study Start: May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

BE (1)